FDA UDI
In Commercial Distribution
🇺🇸 United States
RESOURCE
DI: 04046955210350
·
Model: OF268ZR
·
AESCULAP, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RESOURCE
- Primary DI
- 04046955210350
- Version / Model
- OF268ZR
- Catalog Number
- OF268ZR
- Company Name
- AESCULAP, INC.
- Labeler DUNS
- 082594540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-08
- Public Version
- 1
- Public Version Date
- 2020-05-18
- Public Version Status
- New
- Public Device Record Key
- 343392b6-4e12-4dc6-ae32-386aa5def7f4
Device Description
MG SNELLEN EAR CURETTE CVD SERR160MM
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JYG | CURETTE, EAR | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33416 | Ear spoon | A hand-held manual surgical instrument intended to be used during interventions in the ear to remove or manipulate tissue or anatomical structures. It is usually made of high-grade stainless steel and has a cylindrical handle located centrally from which a shaft protrudes in both directions. These shafts terminate with an operative instrument, one of which is spoon-shaped. The opposite tip may be, e.g., blunt or pointed and possibly at a right angle to the shaft. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046955210350 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]